There are often a number of supply chain configurations and technical options that can be brought to bear with particular serialisation legislative requirements. Short term tactical options have to be weighed against longer term strategic solutions. Some of the challenges that need to be addressed when defining optimal solutions include:
- Differing serialisation models being called for in differing pieces of legislation.
- Uncertainty in the detailed technical requirements as legislation evolves.
- Evolving and competing serialisation standards being developed by standards bodies and industry groups.
- The requirement for many supply chain nodes and assets to be able to handle multiple legislative requirements simultaneously.
- Deciding on the optimal degree of integration of serialisation capabilities with existing capabilities e.g. production control systems and ERP systems.
- Uncertainty in the timing of legislation.
- Striking the optimal balance between providing new equipment versus retrofitting existing equipment.
- Agreeing interfaces and implementation timelines with third parties.
Defining the timing of implementation plans, to a large extent, needs to be considered hand-in-hand with the solutions themselves. One risk that also needs to be considered is that of the ‘last minute rush’, or ‘Y2K effect’. By this we mean the risk that, as is so often the case with this type of legislation, everyone waits until the last minute to implement solutions, only to find that the supply base cannot cope with the peak in demand, driving up cost and forcing companies into non-compliance. This is a particular concern in the 2017 timeframe as the USA, Europe and others all have legislation which becomes effective around this time.